Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERI

FDA device recall Z-1912-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length.

Action taken

Consignees were sent a Medtronic Letter dated March 2008. The letter described the product model / serial number and problem. It gave the option in assisting in returning the product for replacement or credit. A Medtronic Inter-Office Memo was also issued to "Affected Field Personnel" . The memo described the product /problem and the action required . Contact Medtronic Neuromodulation Quality at 651-367-0628 if you have questions.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

LGW

Quantity affected

3

Distribution

NC, FL

Date initiated

2008-03-01

Date posted

2008-09-16

Date terminated

2012-06-05

Location

Minneapolis, MN